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WO2005118014A3 - Decellurisation processes for making bioprotheses - Google Patents

Decellurisation processes for making bioprotheses Download PDF

Info

Publication number
WO2005118014A3
WO2005118014A3 PCT/US2005/018578 US2005018578W WO2005118014A3 WO 2005118014 A3 WO2005118014 A3 WO 2005118014A3 US 2005018578 W US2005018578 W US 2005018578W WO 2005118014 A3 WO2005118014 A3 WO 2005118014A3
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
ionic
detergent
ionic detergent
transplantation
Prior art date
Application number
PCT/US2005/018578
Other languages
French (fr)
Other versions
WO2005118014A2 (en
Inventor
Yuichiro Ueda
Mark W Torrianni
F M Everaerts
Paul V Trescony
F J L Everaerts
Hartog Wifred Den
Original Assignee
Medtronic Inc
Yuichiro Ueda
Mark W Torrianni
F M Everaerts
Paul V Trescony
F J L Everaerts
Hartog Wifred Den
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US10/858,174 external-priority patent/US20050266390A1/en
Application filed by Medtronic Inc, Yuichiro Ueda, Mark W Torrianni, F M Everaerts, Paul V Trescony, F J L Everaerts, Hartog Wifred Den filed Critical Medtronic Inc
Publication of WO2005118014A2 publication Critical patent/WO2005118014A2/en
Publication of WO2005118014A3 publication Critical patent/WO2005118014A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/34—Muscles; Smooth muscle cells; Heart; Cardiac stem cells; Myoblasts; Myocytes; Cardiomyocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3625—Vascular tissue, e.g. heart valves

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Transplantation (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Botany (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Developmental Biology & Embryology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biotechnology (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Methods for decellularizing mammalian tissue for use in transplantation and tissue engineering. The invention includes methods for simultaneous application of an ionic detergent and a nonionic detergent for a long time period, which may exceed five days. One method utilizes SDS as the ionic detergent and Triton-X 100 as the nonionic detergent. A long rinse step follows, which may also exceed five days in length. This long duration, simultaneous extraction with two detergents produced tissue showing stress-strain curves and DSC data similar to that of fresh, unprocessed tissue. The processed tissue is largely devoid of cells, has the underlying structure essentially intact, and also shows a significantly improved inflammatory response relative to fresh tissue, even without glutaraldehyde fixation. Significantly reduced in situ calcification has also been demonstrated relative to glutaraldehyde fixed tissue. Applicants believe the ionic and non-ionic detergents may act synergistically to bind protein to the ionic detergent and may remove an ionic detergent-protein complex from the tissue using the non-ionic detergent. The present methods find one exemplary use in decellularizing porcine heart valve leaflet and wall tissue for use in transplantation.
PCT/US2005/018578 2004-06-01 2005-05-26 Decellurisation processes for making bioprotheses WO2005118014A2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US10/858,174 US20050266390A1 (en) 2004-06-01 2004-06-01 Processes for removing cells and cell debris from tissue and tissue constructs used in transplantation and tissue reconstruction
US10/858,174 2004-06-01
US65776405P 2005-03-01 2005-03-01
US60/657,764 2005-03-01

Publications (2)

Publication Number Publication Date
WO2005118014A2 WO2005118014A2 (en) 2005-12-15
WO2005118014A3 true WO2005118014A3 (en) 2006-06-22

Family

ID=35115755

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/018578 WO2005118014A2 (en) 2004-06-01 2005-05-26 Decellurisation processes for making bioprotheses

Country Status (1)

Country Link
WO (1) WO2005118014A2 (en)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007025233A1 (en) 2005-08-26 2007-03-01 Regents Of The University Of Minnesota Decellularization and recellularization of organs and tissues
US9682173B2 (en) * 2008-06-11 2017-06-20 The Children's Mercy Hospital Solutions for tissue engineering and methods of use
US8435305B2 (en) 2010-08-31 2013-05-07 Zimmer, Inc. Osteochondral graft delivery device and uses thereof
EP2611472B1 (en) 2010-09-01 2016-02-10 Regents of the University of Minnesota Methods of recellularizing a tissue or organ for improved transplantability
US9290738B2 (en) 2012-06-13 2016-03-22 Miromatrix Medical Inc. Methods of decellularizing bone
CN105164250A (en) 2013-03-15 2015-12-16 米罗马特里克斯医疗公司 Use of perfusion decellularized liver for islet cell recellularization
US10537662B2 (en) 2013-07-31 2020-01-21 Biotronik Ag Method for preparing biological tissue
EP2832379B1 (en) 2013-07-31 2015-07-22 Biotronik AG Method for the treatment of biological tissue
US10293082B2 (en) * 2014-07-23 2019-05-21 Clemson University Research Foundation Decellularization method and system and decellularized tissue formed thereby
EP3509651B1 (en) 2016-09-06 2022-12-28 Miromatrix Medical Inc. Use of resected liver serum for whole liver engineering
CN107233622B (en) * 2017-06-20 2020-05-15 爱美客技术发展股份有限公司 Preparation method of acellular tissue membrane
WO2019241499A1 (en) 2018-06-13 2019-12-19 Miromatrix Medical Inc. Fistula filler and deployment system
US11998662B1 (en) 2021-06-09 2024-06-04 Reprise Biomedical, Inc. Biologic matrix for a wound site and related methods

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4553974A (en) * 1984-08-14 1985-11-19 Mayo Foundation Treatment of collagenous tissue with glutaraldehyde and aminodiphosphonate calcification inhibitor
US4801299A (en) * 1983-06-10 1989-01-31 University Patents, Inc. Body implants of extracellular matrix and means and methods of making and using such implants
WO1995024873A1 (en) * 1994-03-14 1995-09-21 Cryolife, Inc. Treated tissue for implantation and preparation methods
US20020115208A1 (en) * 2000-08-16 2002-08-22 Shannon Mitchell Decellularized tissue engineered constructs and tissues

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4801299A (en) * 1983-06-10 1989-01-31 University Patents, Inc. Body implants of extracellular matrix and means and methods of making and using such implants
US4553974A (en) * 1984-08-14 1985-11-19 Mayo Foundation Treatment of collagenous tissue with glutaraldehyde and aminodiphosphonate calcification inhibitor
WO1995024873A1 (en) * 1994-03-14 1995-09-21 Cryolife, Inc. Treated tissue for implantation and preparation methods
US20020115208A1 (en) * 2000-08-16 2002-08-22 Shannon Mitchell Decellularized tissue engineered constructs and tissues

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
JONES M ET AL: "Anticalcification treatments of bioprosthetic heart valves: in vivo studies in sheep.", JOURNAL OF CARDIAC SURGERY. MAR 1989, vol. 4, no. 1, March 1989 (1989-03-01), pages 69 - 73, XP009055892, ISSN: 0886-0440 *
JONES M ET AL: "The effects of anticalcification treatments on bioprosthetic heart valves implanted in sheep.", ASAIO TRANSACTIONS / AMERICAN SOCIETY FOR ARTIFICIAL INTERNAL ORGANS. 1988 OCT-DEC, vol. 34, no. 4, October 1988 (1988-10-01), pages 1027 - 1030, XP009055891, ISSN: 0889-7190 *
KASIMIR M -T ET AL: "Comparison of different decellularization procedures of porcine heart valves.", INTERNATIONAL JOURNAL OF ARTIFICIAL ORGANS, vol. 26, no. 5, May 2003 (2003-05-01), pages 421 - 427, XP009055893, ISSN: 0391-3988 *

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Publication number Publication date
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